MAUDE Adverse Event Report: ASAHI KASEI MEDICAL CO., LTD. PLASMAFLO OP; PLASMA SEPARATOR

Model Number OP-05D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

The product of this event was not returned to the manufacturer and could not be analyzed.The lot number of the product was not reported, and we could not review the manufacturing and quality control records.The physician's commented that this event is non-serious and the causal relationship between this event and plasmaflo op-05d and/or cascadeflo ec-20w was suspicious because adverse event occurred during treatment.We considered that this event as "serious" because the blood pressure was decreased to 68 mmhg and administering medication was required for treatment.Also, we considered the causal relationship between the event and plasmaflo op-05d could not be denied because the patient experienced adverse event during the treatment and the physician commented as above.Hypotonia which is convertible term of hypotension is described in e.Precautions of ifu as "13 monitor the patient constantly during treatment with the plasmaflo¿ op-05w(a).In the event of any of the following during treatment, immediately ensure the safety of the patient and take appropriate measures in accordance with the directions of the responsible physician.Headache, nausea, vomiting, discomfort, chest pain, abdominal pain, hypotonia, hypertension, violent coughing, difficulty breathing, poor complexion, edema of eyelids, heart palpitation, dizziness, pyrexia, chill, causalgia, abnormal sweating, paresthesia, urticaria, muscle cramps, tinnitus, abnormal stimulation of the lachrymal glands, nasal blockage, or complaints of abnormal sensations of taste, smell, or itching, or any other adverse reaction or side effect observed in the patient." we will continue to monitor the occurrence of similar events carefully.

Event Description

This case occurred in (b)(6).We received this report from medical engineer who is the initial reporter of this incident.The adverse event of "blood pressure decreased" was occurred when the double filtration plasmapheresis (dfpp) treatment was performed for the purpose of antibody removal in patient with diabetic nephropathy who was planning to have an abo-incompatible kidney transplant.09:50 dfpp treatment was performed using the medical device of plasmaflo op-05d, which is used as plasma separator and is a similar product to plasmaflo op-05w(a) marketed in us, and cascadeflo ec-20w which separates substances in a certain molecular weight region from separated plasma and is marketed in (b)(6).Hemodialysis (hd) was also performed using another manufacturer's dialyzer during the treatment of dfpp.The patient's blood pressure at the start of treatment was 160/80 mmhg.10:15 the patient complained of chest pain.His lower limbs were elevated, dfpp and hd treatment were stopped, and etilefrine hydrochloride and oxygen were administered.10:18 hydroxyzine hydrochloride was administered.10:30 blood pressure was decreased to 68/41 mmhg and pulse was 50 to 60 per minute.Normal saline and methylprednisolone sodium succinate were administered.10:45 dfpp treatment was restarted.11:00 since the patient complained of chest pain and systolic blood pressure was 70 mmhg, dfpp treatment was discontinued.

• Brand Name: PLASMAFLO OP
• Type of Device: PLASMA SEPARATOR
• Manufacturer (Section D): ASAHI KASEI MEDICAL CO., LTD.; 1-1-2 yurakucho; chiyoda-ku; tokyo, 100-0 006; JA 100-0006
• Manufacturer (Section G): ASAHI KASEI MEDICAL MT CORP.; oita works; 2111-2 oaza sato; oita-shi, 870-0 396; JA 870-0396
• Manufacturer Contact: naomi kagami ; 1-1-2 yurakucho; chiyoda-ku; tokyo, 100-0-006 ; JA 100-0006
• MDR Report Key: 10668336
• MDR Text Key: 211306036
• Report Number: 8010002-2020-00100
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P820033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OP-05D
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR